Healthy
Conditions
Brief summary
Study CSL324\_1003 is a single center, randomized, double-blind, placebo-controlled study designed to characterize and compare the PK properties and safety of a single subcutaneous dose of CSL324 in healthy Japanese and White subjects.
Interventions
BIOLOGICALCSL324
Sterile solution of recombinant anti G-CSF receptor monoclonal antibody for injection
DRUGPlacebo
Sterile solution of CSL324 formulation buffer for injection
Sponsors
CSL Behring
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female Japanese or White subjects aged 20 and 55 years, inclusive * Body weight of at least 45 kg to 100 kg, inclusive * Body mass index of 18.0 to 32.0 kg/m2, inclusive
Exclusion criteria
* A clinically significant medical condition, disorder, or disease of any organ system. * Concurrent diagnosis of malignancy or history of malignancy (except for nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for at least 3 months before Screening). * Immunosuppressive conditions and / or currently taking immunosuppressive or immunomodulative therapy. * Clinically significant abnormalities on physical examination, vital signs, or laboratory assessments, or neutropenia (defined as absolute neutrophil count \< 2.0 × 109/L). * History of chronic or recurrent infections, clinical signs of active infection and / or fever, current / history of serious infection or hospitalized or received IV antibiotics for an infection in previous 2 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) of CSL324 in serum | From Day 1 to Day 56 |
| Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL324 in serum | From Day 1 to Day 56 |
| Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL324 in serum | From Day 1 to Day 56 |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach Cmax (Tmax) for CSL324 in serum | From Day 1 to Day 56 |
| Number of subjects with treatment-emergent adverse events (TEAEs) by incidence, by severity, and by causality | Up to Day 56 |
| Terminal half-life (t1/2) for CSL324 in serum | From Day 1 to Day 56 |
| Percentage of subjects with TEAEs by incidence, by severity, and by causality | Up to Day 56 |
| Apparent volume of distribution (Vz/F) for CSL324 in serum | From Day 1 to Day 56 |
| Number of subjects with or without anti-CSL324 antibodies | Up to Day 56 |
| Percentage of subjects with or without anti-CSL324 antibodies | Up to Day 56 |
| Apparent clearance (CL/F) for CSL324 in serum | From Day 1 to Day 56 |
| Number of subjects with adverse events localized to the administration site by incidence, by severity, and by causality | Up to Day 7 |
| Percentage of subjects with adverse events localized to the administration site by incidence, by severity, and by causality | Up to Day 7 |
Countries
Australia
Outcome results
None listed